• J. Bone Miner. Res. · Sep 2005

    Randomized Controlled Trial Multicenter Study

    Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment.

    • Richard Prince, Adrien Sipos, Anwar Hossain, Unni Syversen, Sophia Ish-Shalom, Ewa Marcinowska, Johan Halse, Robert Lindsay, Gail P Dalsky, and Bruce H Mitlak.
    • Department of Endocrinology and Diabetes and University of Western Australia, Sir Charles Gairdner Hospital, Nedlands, Australia.
    • J. Bone Miner. Res. 2005 Sep 1; 20 (9): 1507-13.

    UnlabelledA follow-up in 1262 women was conducted after the discontinuation of teriparatide. The hazard ratio for combined teriparatide group (20 and 40 microg) for the 50-month period after baseline was 0.57 (p = 0.002), suggesting a sustained effect in reducing the risk of nonvertebral fragility fracture.IntroductionTreatment with teriparatide [rhPTH(1-34)] 20 and 40 microg once-daily subcutaneous dosing significantly reduced the risk of nonvertebral fragility fractures over a median exposure of 19 months.Materials And MethodsAll participants in the Fracture Prevention Trial were invited to participate in a follow-up study. Prior treatment assignments were revealed, and patients were able to receive osteoporosis treatments without restriction.ResultsApproximately 60% of the 1262 patients received an osteoporosis treatment at some time during follow-up, with greater use in the former placebo group than in the combined former teriparatide group (p < 0.05). The hazard ratios for nonvertebral fragility fractures in each teriparatide group relative to placebo were statistically significant for the 50-month period including treatment and follow-up (p < 0.03). In the follow-up period, the hazard ratio was significantly different between the 40 mug and combined groups versus placebo but not for the 20 microg group versus placebo. However, the 20 and 40 microg groups were not different from each other. Kaplan-Meier analysis of time to fracture showed that the fracture incidence in the former placebo and teriparatide groups diverged during the 50-month period including teriparatide treatment and follow-up (p = 0.009). Total hip and femoral neck BMD decreased in teriparatide-treated patients who had no follow-up treatment; BMD remained stable or further increased in patients who received a bisphosphonate after teriparatide treatment.ConclusionsWhile the study design is observational, the results support a sustained effect of teriparatide in reducing the risk of nonvertebral fragility fractures up to 30 months after discontinuation of treatment.

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